Z-0997-2020 Class II Terminated
FDA device recall Z-0997-2020 was initiated by Roche Diabetes Care, Inc. on Dec 11, 2019 and is designated Class II. Reason for recall: Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions The recall status is terminated (terminated Jul 8, 2022). Affected quantity: 82,332 vials.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 12, 2020
- Initiation Date
- Dec 11, 2019
- Termination Date
- Jul 8, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82,332 vials
Product Description
Accu-Chek Aviva Plus Health Network Strips- intended for Blood Glucose Monitoring System Catalog Number: 06908349001
Reason for Recall
Inability to dose the test strips, may result in a temporary inability to get a result that could lead to a delay in treatment and/or therapy decisions
Distribution Pattern
Nationwide: Foreign: Austalia, India
Code Information
Lot Number: 497864 NDC: 65702-0438-10 UPC: 3-65702-43810-1
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0997-2020
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026